En studie av TAR-200 i kombinasjon med Cetrelimab, TAR-200 alene eller Cetrelimab alene hos deltakere med ikke-muskelinvasiv blærekreft (NMIBC) som ikke reagerer på intravesical Bacillus Calmette-Guérin som ikke er kvalifisert for eller valgt til ikke å gjennomgå radikal cystektomi (SunRISe-1)
2. november 2026 oppdatert av: Janssen Research & Development, LLC
Fase 2b klinisk studie som evaluerer effektiviteten og sikkerheten til TAR-200 i kombinasjon med Cetrelimab, TAR-200 alene eller Cetrelimab alene hos deltakere med høyrisiko ikke-muskelinvasiv blærekreft (NMIBC) som ikke reagerer på intravesikal Bacillus Calmette-Guérin (BCG) Hvem er ikke kvalifisert for eller valgt til ikke å gjennomgå radikal cystektomi
The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
220
Fase
- Fase 2
Utvidet tilgang
Godkjent for salg til publikum.
Se utvidet tilgangspost.
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bedford Park, Australia, 5042
- Flinders Medical Centre
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Box Hill, Australia, 3128
- Eastern Health Research
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Sydney, Australia, 2109
- Macquarie University Hospital
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Assebroek, Belgia, 8310
- AZ Sint-Lucas Brugge
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Bruges, Belgia, 8000
- AZ Sint-Jan Brugge
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Brussels, Belgia, 1070
- Hopital Erasme
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Ghent, Belgia, 9000
- Universitair Ziekenhuis Gent
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Ghent, Belgia, 9000
- Algemeen ziekenhuis Maria Middelares
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Roeselare, Belgia, 8800
- Algemeen Ziekenhuis Delta
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Sint-Niklaas, Belgia, 9100
- AZ Nikolaas
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British Columbia
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Abbotsford British Columbia, British Columbia, Canada, V2S 3N5
- Exdeo Clinical Research Inc
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- William Osler Health System
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital- UHN
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre
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Sherbrooke, Quebec, Canada, J1H 5H3
- Universite de Sherbrooke
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Arizona
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Tucson, Arizona, Forente stater, 85715
- Del Sol Research Management, LLC
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California
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Los Angeles, California, Forente stater, 90033
- University of Southern California
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Sherman Oaks, California, Forente stater, 91411
- Genesis Healthcare Partners - Genesis Research Greater Los Angeles
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Colorado
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Denver, Colorado, Forente stater, 80211
- The Urology Center of Colorado
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Golden, Colorado, Forente stater, 80401
- Foothills Urology - Golden Off
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Illinois
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Lisle, Illinois, Forente stater, 60532
- DuPage Medical Group
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Indiana
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Greenwood, Indiana, Forente stater, 46143
- Urology of Indiana
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Kansas
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Wichita, Kansas, Forente stater, 67226
- Wichita Urology Group
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Michigan
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Troy, Michigan, Forente stater, 48084
- Michigan Institute of Urology
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New York
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New York, New York, Forente stater, 10017
- NYU Langone Health
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Syracuse, New York, Forente stater, 13210
- Associated Medical Professionals
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Syracuse, New York, Forente stater, 13210-2375
- SUNY Upstate Medical University
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
- Levine Cancer Institute
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Ohio
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Cincinnati, Ohio, Forente stater, 45212
- The Urology Group
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, Forente stater, 19004
- Urologic Consultants of Southeastern Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University Medical Center
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Nashville, Tennessee, Forente stater, 37209
- Urology Associates, PC
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Texas
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Austin, Texas, Forente stater, 78745
- Urology Austin
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Dallas, Texas, Forente stater, 75390
- University of Texas Southwestern Medical Center
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San Antonio, Texas, Forente stater, 78229
- Urology San Antonio Research
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Washington
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Spokane, Washington, Forente stater, 99202
- Spokane Urology
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Bordeaux, Frankrike, 33076
- Hopital Pellegrin CHU Bordeaux
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Bordeaux, Frankrike, 33300
- Polyclinique Bordeaux Nord Acquitaine
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Grenoble, Frankrike, 38043
- CHU Grenoble
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Hyères, Frankrike, 83400
- Clinique Sainte Marguerite
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Limoges, Frankrike, 87000
- Polyclinique de Limoges - Francois Chenieux
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Lyon, Frankrike, 69437
- Hôpital Edouard Herriot
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Marseille, Frankrike, 13273
- Institut Paoli-Calmettes
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Montpellier, Frankrike, 34070
- Centre de Cancerologie du Grand Montpellier
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Nîmes, Frankrike, 30029
- CHU Nimes
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Paris, Frankrike, 75010
- Hopital Saint Louis
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Paris, Frankrike, 75013
- Hôpital Universitaire Pitié-Salpêtrière
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Paris, Frankrike, 75877
- Hopital Bichat Claude Bernard
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Paris, Frankrike, 75020
- Groupe Hospitalier Diaconesses Croix Saint Simon
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Paris, Frankrike, 75015
- Hopital Europeen Georges-Pompidou
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Quint-Fonsegrives, Frankrike, 31130
- Clinical La Croix Du Sud - Ramsay Santé
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Rennes, Frankrike, 35033
- Hopital Pontchaillou
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Saint-Grégoire, Frankrike, 35760
- CHP Saint Gregoire
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Strasbourg, Frankrike, 67200
- Institut de Cancerologie Strasbourg Europe ICANS
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Suresnes, Frankrike, 92151
- Hopital Foch
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Toulouse, Frankrike, 31059
- Hopital Rangueil
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Cholargós, Hellas, 155 62
- Metropolitan General A E
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Marousi, Hellas, 151 25
- Athens Medical Center
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Thessaloniki, Hellas, 54645
- Euromedica General Clinic
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Thessaloniki, Hellas, 546 22
- Bioclinic - Thessaloniki
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Thessaloniki, Hellas, 54635
- General Hospital of Thessaloniki G. Gennimatas
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Thessaloniki, Hellas, TK 56403
- Papageorgiou General Hospital Of Thessaloniki
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Bari, Italia, 70120
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
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Bari, Italia, 70124
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Satellite 1
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Florence, Italia, 50135
- Azienda Ospedaliera Universitaria Careggi
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Genova, Italia, 16132
- Ospedale San Martino 1
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Milan, Italia, 20132
- Ospedale San Raffaele
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Pisa, Italia, 56126
- Azienda Ospedaliero Universitaria Pisana
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Roma, Italia, 00189
- Azienda Ospedaliera Sant Andrea
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Rome, Italia, 00144
- Istituto Nazionale Tumori Regina Elena
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Torino, Italia, 10126
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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Varese, Italia, 21100
- Ospedale di Circolo e Fondazione Macchi
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Vicenza, Italia, 36100
- Ospedale San Bortolo
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Iizuka, Japan, 820-8501
- Aso Co.,Ltd Iizuka Hospital
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Kanagawa, Japan, 216 8511
- St Marianna University Hospital
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Kashihara-shi, Japan, 634-8522
- Nara Medical University Hospital
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Kisarazu-shi, Japan, 292-8535
- Kimitsu Chuo Hospital
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Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Osaka, Japan, 591-8025
- JOHAS Osaka Rosai Hospital
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Tokyo, Japan, 105-8470
- Toranomon Hospital
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Toyama, Japan, 930-0194
- Toyama University Hospital
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Toyoake, Japan, 470-1192
- Fujita Health University Hospital
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Tsukuba, Japan, 305-8520
- University of Tsukuba Hospital
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Yokohama, Japan, 232 0024
- Yokohama City University Medical Center
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Amsterdam, Nederland, 1066 CX
- Antoni van Leeuwenhoek
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Eindhoven, Nederland, 5623EJ
- Catharina Ziekenhuis
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Nijmegen, Nederland, 6532SZ
- Canisius-Wilhelmina Ziekenhuis
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Utrecht, Nederland, 3508 GA
- The Julius Center - Utrecht Science Park - Stratenum
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Almada, Portugal, 2805-267
- Hospital Garcia de Orta
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Aveiro, Portugal, 3810-193
- Uls Regiao Aveiro - Hosp. Infante D. Pedro
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Guimarães, Portugal, 4835-044
- Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
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Lisbon, Portugal, 1400-038
- Fund. Champalimaud
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Lisbon, Portugal, 1150-199
- Centro Hospitalar de Lisboa Central
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Loures, Portugal, 2674 514
- Uls Loures Odivelas - Hosp. Loures
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Porto, Portugal, 4200-072
- Instituto Portugues de Oncologia do Porto Francisco Gentil
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Vila Nova de Gaia, Portugal, 4434 502
- Centro Hospitalar de Vila Nova de Gaia Espinho E P E
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Vila Real, Portugal, 5000508
- Centro Hospitalar de Trás os Montes e Alto-Douro
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Moscow, Russland, 125284
- Hertzen Oncology Research Institute
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Nizhny Novgorod, Russland, 603074
- Privolzhsky District Medical Centre
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Novosibirsk, Russland, 630099
- Avicenna Medical Center
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Obninsk, Russland, 249031
- A. Tsyb Medical Radiological Research Center
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Omsk, Russland, 644013
- BHI of Omsk region Clinical Oncology Dispensary
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Pyatigorsk, Russland, 357502
- Ultrasound Clinic 4D
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Saratov, Russland, 410054
- Saratov State Medical University
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Tyumen, Russland, 625041
- Multifunctional clinical medical center 'Medical city'
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Ufa, Russland, 450008
- Bashkir State Medical University
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A Coruña, Spania, 15006
- Hosp Univ A Coruna
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Badalona, Spania, 08916
- Hosp. Univ. Germans Trias I Pujol
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Barcelona, Spania, 08025
- Fund. Puigvert
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Cadiz, Spania, 11009
- Hosp. Puerta Del Mar
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Granada, Spania, 18014
- Hosp. Univ. Virgen de Las Nieves
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Jerez de la Frontera, Spania, 11407
- Hosp. de Jerez de La Frontera
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Madrid, Spania, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Spania, 28034
- Hosp. Univ. Ramon Y Cajal
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Madrid, Spania, 28046
- Hosp. Univ. La Paz
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Madrid, Spania, 28050
- Hosp Univ Hm Sanchinarro
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Málaga, Spania, 29010
- Hosp Virgen de La Victoria
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Sabadell, Spania, 08208
- Corporacio Sanitari Parc Tauli
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Valencia, Spania, 46009
- Instituto Valenciano de Oncologia
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Glasgow, Storbritannia, G12 0YN
- NHS Greater Glasgow and Clyde
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Leeds, Storbritannia, LS9 7TF
- Leeds Teaching Hospitals NHS Trust
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Busan, Sør -Korea, 612-896
- Inje University Haeundae Paik Hospital
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Daegu, Sør -Korea, 41404
- Kyungpook National University Chilgok Hospital
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Daegu, Sør -Korea, 42601
- Keimyung University Dongsan Hospital
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Goyang-si, Sør -Korea, 10408
- National Cancer Center
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Gwangju, Sør -Korea, 61469
- Chonnam National University Hospital
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
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Seoul, Sør -Korea, 03722
- Severance Hospital
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Seoul, Sør -Korea, 06273
- Gangnam Severance Hospital
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Seoul, Sør -Korea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Yangsan, Sør -Korea, 50612
- Pusan National University Yangsan Hospital
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Cologne, Tyskland, 50968
- Urologische Partnerschaft Koln UPK
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Duisburg, Tyskland, 47169
- Urologicum Duisburg
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Herne, Tyskland, 44625
- Klinikum Herne - Urologie
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Markkleeberg, Tyskland, 04416
- Matthias Schulze - Germany
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Mettmann, Tyskland, 40822
- Urologie Neandertal Praxis Mettmann
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Münster, Tyskland, 48149
- Universitatsklinikum Munster
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Nuremberg, Tyskland, 90491
- Schön Klinik Nürnberg Fürth
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Nürtingen, Tyskland, 72622
- Studienpraxis Urologie Nürtingen - Germany
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Würselen, Tyskland, 52146
- Urologische Praxis am Wasserturm - Germany
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Chernihiv, Ukraina, 14029
- Chernihivskyi oblasnyi onkolohichnyi dyspanser
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Kiev, Ukraina, 08173
- Asklepion LLC
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Sumy, Ukraina, 40022
- Sumy Regional Clinical Oncology Centre
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ [CIS] or tumor in situ [Tis]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
- All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma [HGUC])
- Participants must be ineligible for or have elected not to undergo radical cystectomy
- BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
- Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2
Exclusion Criteria:
- Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
- Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
- Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)
- Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cohort 1: TAR-200 and Cetrelimab
TAR-200 is placed into the bladder through a urinary placement catheter in participants with carcinoma in situ (CIS), with or without papillary disease, on Day 0 and will be dosed every 3 weeks (Q3W) for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). In addition, Cetrelimab will be dosed Q3W through Week 78 (18 months). |
TAR-200 will be administered transuretherally.
Andre navn:
Cetrelimab will be administered.
Andre navn:
|
|
Eksperimentell: Cohort 2: TAR-200
TAR-200 is placed into the bladder through a urinary placement catheter in participants with CIS, with or without papillary disease, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). |
TAR-200 will be administered transuretherally.
Andre navn:
|
|
Eksperimentell: Cohort 3: Cetrelimab
Participants with CIS, with or without papillary disease, will receive Cetrelimab which will be dosed Q3W through Week 78 (18 months). |
Cetrelimab will be administered.
Andre navn:
|
|
Eksperimentell: Cohort 4: TAR-200 (Participants with Papillary Disease only)
TAR-200 is placed into the bladder through a urinary placement catheter in participants with papillary disease only, on Day 0 and will be dosed Q3W for up to the first 24 weeks (6 months), then every 12 weeks through Week 99 (Year 2). |
TAR-200 will be administered transuretherally.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
Tidsramme: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point. |
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
|
Cohort 4: Disease-free Survival (DFS)
Tidsramme: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to [>=] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause. |
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ) -C30 Scores
Tidsramme: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Change From Baseline in EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Tidsramme: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Time to Symptom Deterioration as Assessed by European Organisation for Research and Treatment of Cancer Qualityof-life Questionnaire (EORTC QLQ) -C30 Scores
Tidsramme: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Time to Symptom Deterioration as Assessed by EORTC QLQ- Non-Muscle-Invasive Bladder Cancer (NMIBC) 24 Scores
Tidsramme: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Number of Participants With Adverse Events (AEs) by Severity Grades
Tidsramme: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Number of Participants With Clinical Laboratory Abnormalities by Severity Grades
Tidsramme: From Week 0 up to 6 years 7 months
|
From Week 0 up to 6 years 7 months
|
|
|
Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
Tidsramme: From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
|
DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported. |
From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Tidsramme: Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
|
Plasma concentrations of gemcitabine and dFdU were reported. |
Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose
|
|
Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
Tidsramme: At Week 0
|
Cmax was defined as maximum observed urine concentration. |
At Week 0
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Tidsramme: At Weeks 3, 6, 9, 15, 18, and 21
|
Urine concentrations of gemcitabine and dFdU were reported. |
At Weeks 3, 6, 9, 15, 18, and 21
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Tidsramme: At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
|
Serum concentration of cetrelimab were reported. |
At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]
|
|
Cohort 3: Serum Concentration of Cetrelimab
Tidsramme: At Weeks 60 (EOI)
|
Serum concentration of cetrelimab were reported. |
At Weeks 60 (EOI)
|
|
Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
Tidsramme: From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
|
Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis. |
From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. desember 2020
Primær fullføring (Faktiske)
3. juli 2025
Studiet fullført (Antatt)
30. september 2027
Datoer for studieregistrering
Først innsendt
20. november 2020
Først innsendt som oppfylte QC-kriteriene
20. november 2020
Først lagt ut (Faktiske)
23. november 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR108921
- 2020-002646-16 (EudraCT-nummer)
- 17000139BLC2001 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-506146-23-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .